Question

Which of the following is correct about robustness and ruggedness in method validation?

• A. Robustness evaluates inter-laboratory variations, while ruggedness evaluates small changes in method parameters
• B. Ruggedness evaluates inter-laboratory variations, while robustness evaluates small changes in method parameters
• C. Robustness focuses on analyst variations, while ruggedness evaluates intra-laboratory changes
• D. Ruggedness focuses on temperature changes, while robustness focuses on pressure changes

Hint:

Remember: Ruggedness = inter-lab consistency; Robustness = resistance to small deliberate changes.

Answer 1

The Correct Option is B

In method validation: - Ruggedness refers to the degree of reproducibility of test results under varied conditions such as different laboratories, analysts, or instruments. - Robustness refers to the capacity of a method to remain unaffected by small, deliberate variations in method parameters, thus indicating its reliability during normal usage.